Effect of left and right lateral positioning on gastroesophagel reflux (GER) and underlying mechanisms in GER disease patients and healthy controls

• Conditions: heartburn; Reflux; 10017977

• Registration Number: NL-OMON33184
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

GERD
* Written informed consent.
* >18 yr of age.
* 2 of the following criteria:
o GERD proved by pH-monitoring with reflux index >5.8% (Richter et al 1992).
o Combined pH-MII monitoring with SAP>95%
o Reflux esophagitis * grade I as confirmed by endoscopy.
* GERD symptoms > 3 months and >2x per week.
Healthy controls
* Written informed consent.
* >18 yr of age.
* No GERD symptoms or

Exclusion Criteria

Exclusion criteria
* Previous gastro-intestinal surgery (with the exception of appendectomy).
* Any condition that will make it unsafe the subject to participate.
* Congenital abnormalities affecting the gastro-intestinal tract.
* Mental retardation.
* Hiatus hernia.
* Gravida.
* Any condition that will make discontinuation of medication impossible, as determined by the treating physician.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Time to first TLESR 2) Number of TLESRs in the first 15 minutes 3) Total<br /><br>number of TLESRs 4) Cumulative 13C excretion at first TLESR 5) Gastric volume<br /><br>(number of voxels) at first TLESR. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Total number of acid/ weakly acidic/ weakly alkaline GER episodes 2) Total<br /><br>number of liquid/mixed/gas GER 3) Total gastric volume (number of voxels) 4)<br /><br>Total gastric emptying time</p><br>